Status:
WITHDRAWN
Uterine Artery Embolization and Pelvic Floor Symptoms
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Leiomyoma
Incontinence
Eligibility:
FEMALE
18-80 years
Brief Summary
The objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well.
Eligibility Criteria
Inclusion
- female
- age 18-80 years
- symptomatic uterine fibroids
- scheduled for UAE
- Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture (Urine dipstick is performed as standard of care)
- Available for 12-months of follow-up and able to complete study assessments, per clinician judgment
- Signed consent form
Exclusion
- Age \<18 or \>80 years
- women who are unable to read and write English,
- pregnancy or planned pregnancy in the next 12 months
- \< 6 months postpartum
- current use of anticholinergic medication, cholinergic agonists, tricyclic antidepressants, or duloxetine - must have been off such drugs for at least 4 weeks
- women with surgery for urinary incontinence or pelvic organ prolapse in the past 6 months
- history of bladder or pelvic cancer or pelvic radiation therapy
- prior augmentation cystoplasty
- urethral diverticulum, current or repaired.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00827645
Start Date
January 1 2009
End Date
January 1 2013
Last Update
May 22 2018
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390